{"id":2076,"date":"2024-10-31T11:28:17","date_gmt":"2024-10-31T03:28:17","guid":{"rendered":"https:\/\/zjbocon.com\/?p=2076"},"modified":"2025-12-05T11:11:54","modified_gmt":"2025-12-05T03:11:54","slug":"ethylene-oxide-sterilization-chamber","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/?p=2076","title":{"rendered":"PQ in Ethylene oxide sterilization chamber"},"content":{"rendered":"\n
\"Ethylene<\/figure><\/div>\n\n\n\n

PQ este etapa de validare care folosește camera de sterilizare cu oxid de etilenă pentru a demonstra că echipamentul de sterilizare cu oxid de etilenă funcționează în mod constant în conformitate cu criterii de acceptare predeterminate și procesul produce un produs care este steril și îndeplinește cerințele specificate.<\/p>\n\n\n\n

PQ should be carried out for each new process and\/or product to be validated to demonstrate that the process complies with identified acceptance criteria and is capable of delivering the required SAL to the product.PQ consists of both microbiological and physical performance qualifications and is performed in the Ethylene oxide sterilization equipment used to sterilize the product.<\/p>\n\n\n\n

During PQ process, the package of the product and loading mode of the product\u00a0should be specified;\u00a0Select representative products or materials whose packaging and material composition can cover all the product to be sterilized or the entire product family.<\/p>\n\n\n\n

During PQ process, the package of the product and loading mode of the product\u00a0should be specified;\u00a0Select representative products or materials whose packaging and material composition can cover all the product to be sterilized or the entire product family.<\/p>\n\n\n\n

În general, MPQ și PPQ sunt efectuate simultan. Dacă PPQ este efectuat în paralel cu cel puțin trei rulări MPQ, atunci trebuie efectuată cel puțin o rulare PPQ suplimentară utilizând specificația procesului cu ciclu complet. PQ fizică (PPQ) trebuie să demonstreze că criteriile de acceptare specificate sunt îndeplinite pe toată durata încărcăturii pe durata specificației procesului de rutină propus.<\/p>\n\n\n\n

PQ se efectuează pentru introducerea de produse noi sau modificate, ambalaj, configurație de încărcare, cameră de sterilizare cu oxid de etilenă sau parametri de proces, cu excepția cazului în care echivalența cu un produs validat anterior, ambalare, configurație de încărcare a camerei sau procesului de sterilizare cu oxid de etilenă.<\/p>\n\n\n\n

Verificare PQ Procesul camerei de sterilizare cu oxid de etilenă<\/h2>\n\n\n\n

Procesul de verificare PQ este, în general, după cum urmează: efectuați mai întâi un ciclu fracționat și testați starea de sterilitate a produsului după
fracționat
\u00a0cycle sterilization; compare the EO resistance relationship between IPCD, EPCD and representative products (the expected result is EPCD > IPCD > Product,); Refer to ISO-11737-2 for the test requirements involved in the fractional cycle.<\/p>\n\n\n\n

Efectuați jumătate de ciclu pentru a demonstra reproductibilitatea procesului de sterilizare și efectul de sterilizare; Dacă este utilizată metoda overkill, atunci nu ar trebui să existe IPCD pozitiv în timpul semiciclului. EPCD pozitiv în timpul semiciclului sunt acceptabile dacă au demonstrat o rezistență mai mare decât IPCD care oferă o
\u201c
provocare în cel mai rău caz
\u201d
pentru prelucrarea de rutină.<\/p>\n\n\n\n

Parametrii de sterilizare de rutină sunt de obicei determinați de parametrii ciclului complet, astfel încât provocările reziduale sunt în general efectuate în timpul ciclului complet pentru a determina timpul adecvat de aerare. Întrucât eficacitatea procesului de sterilizare a fost dovedită în cicluri de fracțiuni și semicicluri, efectul de sterilizare poate fi asigurat prin EPCD.<\/p>\n\n\n\n

Dacă, în oricare dintre aceste execuții, cerințele de sterilitate sau funcționalitatea produsului nu sunt îndeplinite, ar trebui efectuată o investigație pentru a determina dacă sunt necesare execuții de calificare suplimentare. Dacă parametrii procesului nu pot fi menținuți în limitele definite, trebuie efectuată o investigație. Dacă se fac modificări, trebuie să fie necesare rulări suplimentare.<\/p>\n\n\n\n

PQ anual în procesul camerei de sterilizare cu oxid de etilenă<\/h2>\n\n\n\n

Review of PQ should assessment that the sterilization process remains valid for the designated product.Reduced MPQ\/PPQ can be necessary in certain situations, e.g. to verify continued appropriateness of the resistance of the internal PCD in the product load to the resistance of the product bioburden, or, after a defined interval, to provide evidence that there has been no inadvertent change since the previous requalification study. This would typically include, minimally,one fractional or half cycle exposure including load temperature and humidity measurements. Fractional cycles in a developmental chamber can also be used to support a requalification program, but requalification of the production chamber should be performed in the production chamber.<\/p>\n\n\n\n

Evaluarea echivalenței<\/h2>\n\n\n\n

1.Echivalența procesului? Echipament de sterilizare cu oxid de etilenă care furnizează aceiași parametri de proces, fiind supus IQ<\/a> şi OQ<\/a>, va fi calificat fie.<\/p>\n\n\n\n

2. în același mod ca camera inițială sau folosind un MPQ redus care demonstrează furnizarea nivelului necesar de letalitate microbiologică și PPQ pentru a demonstra uniformitatea temperaturii și umidității încărcăturii și controlul de către camera de producție. Motivul pentru această calificare redusă va fi înregistrat și documentat.<\/p>\n\n\n\n

3. Se determină influența diferitelor locații geografice asupra proprietăților produsului sau încărcăturii.<\/p>\n\n\n\n

4. Echivalența procesului este o metodă utilizată pentru a demonstra că același proces de sterilizare validat este furnizat de două sau mai multe piese sau seturi de echipamente de sterilizare cu oxid de etilenă. Nu necesită ca echipamentul să fie identic din punct de vedere fizic. Chiar dacă parametrii furnizați de echipament nu sunt identici din punct de vedere statistic, procesele livrate pot fi totuși echivalente dacă toate sunt capabile să ruleze procesul în limitele definite și validate ale procesului.<\/p>\n\n\n\n

5. Echivalența procesului între mai multe piese de echipament are scopul de a minimiza cantitatea de teste necesare pentru a califica procesul. Procesul de sterilizare trebuie validat într-o singură cameră. Echipamentul rămas poate suferi un PQ redus dacă echipamentul rămas a fost supus calificării de instalare (IQ) și calificare operațională (OQ) (vezi 9.2 și 9.3). Echivalența poate fi folosită și pentru a reduce recalificarea mai multor echipamente. Echipamentul folosit pentru a furniza un proces de sterilizare constă în mod obișnuit dintr-o cameră sau încăpere și sisteme de control auxiliare. Echipamentul de proces de sterilizare poate fi amplasat într-o anumită unitate de procesare sau între mai multe instalații. Acest echipament poate fi utilizat independent pentru a furniza aceleași condiții de proces și ar putea avea exact același design sau poate diferi în dimensiune sau în amploarea echipamentului auxiliar.<\/p>\n\n\n\n

6. Echivalența procesului între mai multe piese de echipament are scopul de a minimiza cantitatea de teste necesare pentru a califica procesul. Procesul de sterilizare trebuie validat într-o singură cameră. Echipamentul rămas poate suferi un PQ redus dacă echipamentul rămas a fost supus calificării de instalare (IQ) și calificare operațională (OQ) (vezi 9.2 și 9.3). Echivalența poate fi folosită și pentru a reduce recalificarea mai multor echipamente. Echipamentul folosit pentru a furniza un proces de sterilizare constă în mod obișnuit dintr-o cameră sau încăpere și sisteme de control auxiliare. Echipamentul de proces de sterilizare poate fi amplasat într-o anumită unitate de procesare sau între mai multe instalații. Acest echipament poate fi utilizat independent pentru a furniza aceleași condiții de proces și ar putea avea exact același design sau poate diferi în dimensiune sau în amploarea echipamentului auxiliar.<\/p>\n\n\n\n

DACĂ VREI SĂ ȘTII MAI MULTE <\/h2>\n\n\n\n

Telefon:+8619975258603<\/a><\/p>\n\n\n\n

E-mail:hayley@hzbocon.com<\/a><\/p>\n\n\n\n

Site local: Camera 1202, Caitong Zhongxin, districtul Xiasha, orașul Hangzhou, provincia Zhejiang, China<\/p>\n\n\n\n

Site:hzbocon.com<\/a>zjbocon.com<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

PQ este etapa de validare care folosește camera de sterilizare cu oxid de etilenă pentru a demonstra că echipamentul de sterilizare cu oxid de etilenă funcționează în mod constant în conformitate cu criterii de acceptare predeterminate și procesul produce un produs care este steril și îndeplinește cerințele specificate.<\/p>\n","protected":false},"author":234312599,"featured_media":8489,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_uag_custom_page_level_css":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center 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Learn why they are essential for medical and industrial sterilization.","rel":"","context":"In "Company News"","block_context":{"text":"Company News","link":"https:\/\/zjbocon.com\/?cat=133125"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/ethylene-oxide-sterilization-21.webp?resize=350%2C200","width":350,"height":200},"classes":[]},{"id":2471,"url":"https:\/\/zjbocon.com\/?p=2471","url_meta":{"origin":2076,"position":1},"title":"Safety Requirements for Using Ethylene Oxide in sterilization","author":"Bocon Technical Team","date":"2024-12-23","format":false,"excerpt":"when Ethylene Oxide in sterilization chamber should be equipped with fire prevention facilities. Ethylene oxide cylinders should be stored separately in a dry, well-ventilated room, with strict prohibition of smoking and open flames. 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